Warming Liquid Personal Lubricant is primarily intended as a personal lubricant to warming bigule I crocion, and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal or penile tissue for purposes of lubrication, and moisturization. It is also compatible with latex condoms.

Device Description

PharmaPac Warming Liquid is a non-sterile, clear, non-staining, non-greasy, liquid I harmal as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. Warming Liquid with or without a later of a contraceptive or spermicide. It is compatible with latex condoms.

AI/ML Overview

The acceptance criteria and the study proving the device meets them are described below:

Acceptance Criteria and Device Performance

The "PharmaPac Warming Liquid Personal Lubricant" is a personal lubricant, and its performance criteria primarily revolve around safety and compatibility for its intended use. The provided studies validate these aspects.

Acceptance Criteria	Reported Device Performance
Biocompatibility: No evidence of contact sensitization No significant irritation to ocular tissue No significant irritation to vaginal mucosa No systemic toxicity	Biocompatibility Demonstrated: Dermal Sensitization Study (Guinea Pig): No evidence of being a contact sensitizing agent. Intracutaneous Irritation Study (Rabbit): No significant irritation observed. Vaginal Irritation Study (Rabbit): No significant irritation on vaginal mucosa after repeated direct administration. Systemic Injection Study (Mouse): No mortality and not associated with systemic toxicity at specified dosage.
Condom Compatibility (Latex): No significant decrease in burst pressure or volume. No significant decrease in tensile properties (tensile strength, elongation).	Condom Compatibility Demonstrated: Burst Testing: Application of the lubricant showed no significant difference in burst pressure or burst volume results compared to control. Tensile Testing: No decrease in overall values (process force, ultimate tensile strength, elongation at break) was noted when comparing the two lubricants (test and predicate).
Shelf Life / Stability: Maintain specifications over the expected shelf life (e.g., 24 months).	Shelf Life / Stability Demonstrated: Accelerated Stability Study: Stored at 40 ℃ and tested at 0, 50, 60, and 70 days. Product remained within specifications at every testing event, supporting a 24-month shelf life.

Study Details:

Sample sizes used for the test set and the data provenance:
- Dermal Sensitization Study: Albino guinea pigs (specific number not provided).
- Intracutaneous Irritation Study: Rabbits (specific number not provided).
- Vaginal Irritation Study: Rabbits (specific number not provided).
- Systemic Injection Study: Mice (specific number not provided).
- Condom Compatibility Studies: Several brands and varieties of latex condoms. Tested in-vitro.
- Accelerated Stability Study: Samples of the Warming Liquid Personal Lubricant.
The studies were conducted "by an outside In VIVO Standard Laboratory." The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA. The biocompatibility studies appear to be prospective, laboratory animal studies, and the condom compatibility studies are prospective in-vitro tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The preclinical studies (biocompatibility and condom compatibility) described do not typically involve human experts establishing a "ground truth" in the way clinical studies do. The "ground truth" is established by direct observation and measurement in animal models or in-vitro settings based on established scientific protocols (e.g., microscopic tissue examination, burst pressure measurements).
Adjudication method for the test set:
Not applicable to these types of preclinical and in-vitro studies. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess data or images.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a personal lubricant, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical product (personal lubricant), not an algorithm or AI.
The type of ground truth used:
For the biocompatibility studies, the "ground truth" was established through direct histopathological examination (e.g., "microscopic tissue examination showed no significant irritation") and observable biological responses (e.g., "no evidence of being a contact sensitizing agent," "no mortality"). For condom compatibility, the "ground truth" was derived from quantifiable physical measurements (burst pressure/volume, tensile strength/elongation) performed in-vitro.
The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions pertain to pre-market testing of a physical product.
How the ground truth for the training set was established:
Not applicable (as above).

Summary

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K052974

510(k) Summary

Submitter	PharmaPac, LLC110 Industrial Park RoadDeKalb, MS 39328
Contact Person	Tom Otto(601) 743-9771 phone(601) 743-9772 fax
Date Prepared	September 12, 2005
Proprietary Name	PharmaPac Warming Liquid Personal Lubricant
Common Name	Personal Lubricant
Classification Name	Patient Lubricant (per 21 CFR § 880.6375)
Predicate Device	K-Y® Warming Liquid Personal Lubricant (K021492)

Description of Device

Intended Use

Warming Liquid Personal Lubricant is primarily intended as a personal lubricant to wanning Digure friction, and to enhance the ease and comfort of intimate sexual monstanze, roneve methon, and refely applied to vaginal, or penile tissue for purposes activity. This fubrican maj ation. It is also compatible with latex condoms.

Technological Characteristics of Device Compared to Predicate

The technology involved in this product has no remarkable technological The techniology involvou in in the province soluble ingredients similar to other lubricants which are currently on the market. A comparison of technological Idoricallis wither are outromiy on the substantial equivalence of Warming Liquid Characteristics which domonstration and summarized in the Table below:

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510(k) Summary (Cont.)

Comparison of Characteristics

Characteristic / Feature	PharmaPacWarming LiquidPersonal Lubricant	K-Y® BrandWarming Liquid(K021492)
Contains Glycerin	Yes	Yes
Contains Thickening Agents	Yes	Yes
Contains Preservative Agents	Yes	Yes
Contains Petroleum basedChemicals	No	No
Container Material	Plastic	Plastic
Sterile	No	No

Performance Data

I er formatics were conducted on Warming Liquid Personal Lubricant by an outside In VIVO Standor Woonstrated the Biocompatibility of Warming Liquid Personal Lubricant by the following results.

Dermal Sensitization Study (Guinea Pig) – The product exhibited no evidence being a contact sensitizing agent in albino guinea pigs.

a Contact schildling agent in distres growth of this product to the rabbit I enine ITT liation Order on microscopic tissue examination showed no significant irritation.

Stgifficant Irritation:
Vaginal Irritation Study (Rabbit) – Repeated Direct administration of Warming V aginal in Huation Diday (Fuse rabbit vagina and subsequent macroscopic and microscopic tissue examination showed no significant irritation of the vaginal mucosa.

Indecsa.
Systemic Injection Study (Mouse) – The product was administered to the animals at Systemic Infection Study (Mouse) - 1.1. p mortality and was not associated with systemic toxicity.

Studies Condom compatibility were also conducted on Warming Liquid Personal Studies Concom companonity were association was tested in parallel with the predicate Lubricant by a thru-party hooffacts ... ... ... ... ... ... ... ... ... ... .. .. .. .. .. .. .. .. several brands and varieties of latex condoms were tested.

Several brancs and varieties of faces contemb with the test lubricants exhibited Deak testing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Burst testing - Application of the test lubricants showed no significant difference in Durst testing - results for burst pressure or burst volume.

the treathent groups Tesans for barb process force, ultimate tensile strength, and I elisite testing - No decrease in the oreal voted when comparing the two lubricants.

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KO52974

510(k) Summary (Cont.)

In an Accelerated Stability Study the Warming Liquid Personal Lubricant was stored In an Accelerated Bulling Stary ate Alantintervals. The testing showed that at every at 40 ℃ and tested ut 0, 50, 00, and 70 day and remained within specifications testing ovent the production a 24 month shelf life may be supported by this data.

The testing and evaluation of this formulation has demonstrated scientific evidence that this product is safe for its intended use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is written in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

FEB 2 4 2014

PharmaPac, LLC % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K052974

Trade/Device Name: PharmaPac Warming Liquid Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): November 12, 2005 Received (Date on orig SE ltr): November 14, 2005

Dear Mr. Job:

This letter corrects our substantially equivalent letter of December 16, 2005.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 -

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):		(1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1
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Device Name: . PharmaPac Warming Liquid Personal Lubricant

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

радительных провых провых ставляется продавания продавания продавания принастические принасления с

NancyL Brogdon

inminal.

Ko52974

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.